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Aerobic Dance Training in Small Vessel Disease (ADTSVD)

Primary Purpose

Cerebrovascular Disease

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Structured Aerobic Dance Training Group
Stretching plus education
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebrovascular Disease focused on measuring Cerebral small vessel disease, Lifestyle modification, Physical activity, Primary prevention, Aerobic dance, Cognition, Depression, Activities of daily living, Cerebral autoregulation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ≥65
  2. Community dwelling
  3. Presence of significant SVD, defined by the presence of multiple (≥2) lacunar infarcts and/or a rating of ≥2 (i.e. beginning confluence of lesions to diffuse involvement of lesions in periventricular and/or deep white matter) of WML using the Age-related White Matter Changes (ARWMC) Scale on MRI
  4. Presence of good temporal window on at least one side for TCD evaluation
  5. Written informed consent given

Exclusion Criteria:

  1. History of stroke
  2. Dementia, determined by a score on Cantonese MMSE less than education adjusted cutoff score for dementia or history of dementia diagnosis
  3. Comorbidity with medical conditions affecting the central nervous system or cerebral white matter
  4. Inadequately controlled psychiatric disorders affecting cognition and mood
  5. Physical or sensory impediments hindering participation in cognitive assessment or exercise training.

Sites / Locations

  • Chinese University of Hong KongRecruiting
  • Neurology Clinical Research Centre, CUHK

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Structured Aerobic Dance Training Group

Stretching plus education

Arm Description

Active intervention will last for 24 weeks and consists of 60-minute/session, which includes 10 minutes warm-up, 40 minutes of dancing and 10 minutes of cool down. In groups of 5, participants will practice the dance led by a physiotherapist once per week for the first 2 months and twice per week for 3rd to 6th month.

Participants in the control group will receive a weekly 3-hour group-based (group of 5 participants) programme containing stretching exercise, stress reduction and health education on dementia and stroke prevention for 6 months. The programme consists of low-intensity seated stretching, psychoeducation on stress management, various relaxation methods with practice as well as education on the causes, identification, treatment and prevention of stroke and dementia. Benefits of physical exercise will also be discussed but will its weight will be evenly balanced with other forms of evidence-based preventive strategies.

Outcomes

Primary Outcome Measures

Cognition assessed by the 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocol summary score
Depressive symptoms evaluated the Geriatric Depression Scale
Physical balance measured by the Mini-Balance Evaluation Systems Test
Functional mobility measured by the Timed-up-and-go test
Walking capacity assessed by the 6-minute walk test
Daily functioning evaluated by the Lawton's Instrumental Activities of Daily Living

Secondary Outcome Measures

Cerebral vasomotor reactivity measured by Pulsatility Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler
Cerebral vasomotor reactivity measured by Breath Holding Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler

Full Information

First Posted
March 6, 2016
Last Updated
July 17, 2018
Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02730065
Brief Title
Aerobic Dance Training in Small Vessel Disease
Acronym
ADTSVD
Official Title
Effects of Aerobic Dance Training on Cognitive Functions, Mood and Physical Functions in Community Elderly Persons With Cerebral Small Vessel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Introduction: Cerebral small vessel disease (SVD) is associated with age-related disabilities including dementia, depression, physical and functional impairment. Chinese are more prone to developing SVD than Caucasians. Physical exercise may improve multiple negative consequences associated with SVD. Objective and hypothesis to be tested: To examine the effects of a 24-week structured aerobic dance training on cognition, mood, physical and daily functions in stroke and dementia free older adults with SVD, and whether such effects are mediated through improved cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation which is impaired in SVD. Design and subjects: Rater-blind RCT comparing the effects of 24-week of structured aerobic dance training upon cognition, mood, physical and daily functions on 110 community dwelling, stroke- and dementia-free persons aged ≥65 with MRI evidence of significant SVD, defined as the presence of multiple (≥2) lacunes and/or early confluent or confluent WML. Interventions: Participants are randomized in a 1:1 ratio into a 24-week of structured therapist-led group aerobic dance training with home practice or simple stretching plus health education control group. Main outcome measures: Cognition, mood, physical and daily functions and CVR measured using Transcranial Doppler at baseline, weeks 12, 24 and 36. Data analysis: Intent-to-treat with multiple imputations with treatment efficacy analyzed using mixed effects models. Mediation effects of CVR between aerobic dance training and treatment outcomes tested using mediation models. Expected results: In persons with significant SVD, aerobic dance training improves cognitive, mood, physical and daily functions and such effects are mediated by changes in CVR.
Detailed Description
Cerebral small vessel disease (SVD) is manifested as age-related white matter lesions (WML) and lacunar infarcts and on brain imaging. SVD is prevalent in the elderly population. In community dwelling persons ≥ 60 years of age, up to a quarter had lacunar infarcts and 96% had varying degree of WML. Significant SVD, namely early confluent or confluent WML and multiple lacunar infarcts, are found in up to 1 in every 5 elderly persons. In a previous study we found that Chinese are more prone to develop significant SVD than Caucasians. SVD is associated with a plethora of age-related disabilities such as dementia, falls, depression, impaired daily functioning and death Cognition - SVD is the most common cause of vascular cognitive impairment (VCI) and vascular dementia, which is the second most prevalent type of dementia. Community elderly persons with SVD had two-fold increased risk of developing dementia when compared to those without. SVD may direct damage neural structures, disrupt connectivity or cause atrophy in brain regions important for cognitive functioning. Depression - Disconnection of frontosubcortical pathways by SVD contributes to late-life depression, and increased comorbidity of depression and SVD has been observed in the older populations. Depression contributes to poor quality of life and death in older persons. Physical impairment - increased severity of SVD is associated with poor physical functions including poor gait and balance. SVD is a strong risk factor for falls, a major contributing factor for disability and death in older persons. In summary, non-disabled older adults with SVD are at high risk of multiple disabilities. As the elderly population in Hong Kong is projected to triple over the next 30 years, means to prevent age-related disabilities such as cognitive decline, depression and physical impairments in vulnerable individuals are of enormous importance to the patient, family and healthcare system. Existing preventive therapies mainly involve medications to control vascular risk factors associated with SVD. Primary prevention by means of lifestyle intervention is therefore of utmost importance. Evidence on effects of physical activities upon cognition, mood and physical functions The health values of physical activities are well recognized. Physical activities can be performed by anybody at any time and place at minimal cost. Physical activities are shown to improve the clinical conditions associated with SVD. For cognition, physical activities are associated with reduced risk of cognitive decline in normal and cognitively impaired elderly persons. Aerobic and strength training improved executive functions, memory and general cognitive functions in community-dwelling adults with mild cognitive impairment. The investigators showed that in a large cohort (n=1,013) of stroke patients free of dementia before the stroke, participation in regular physical activities reduced 79% of risk of incident dementia after stroke. With regard to the mechanism, physical activities may improve endothelial functions and blood perfusion and neuroplasticity in brain regions mediating cognitive functions. Moreover, physical exercise may protect cognition by reducing incident strokes, which is particular relevant to people with SVD due to their increased risk of strokes. A randomized controlled trial (RCT) showed that a 24-week, 3 x 50-minute per week of moderate intensity exercise intervention significantly improved cognitive functions in patients at risk of AD, with outcome effect size superior to that reported for drug treatment in another study. Moreover, treatment benefits persisted at least one year after active intervention, suggesting that physical exercise is associated with enduring changes in the neurological substrate underpinning cognitive functioning. However, this study only recruited patients likely to have degenerative (Alzheimer's) pathology. For mood, physical activities may protect against depression in older adults. For physical functions, the investigators previously showed that physical exercise training improved balance, gait performance, exercise endurance and quality of life in local patients with Parkinson's Disease (PD). Taken together, there is good evidence that physical activities can improve many of the negative consequences of cerebral SVD. Possible biological mechanism underlying physical exercise in SVD The development of SVD is hypothesized to be related to endothelial dysfunction that results from chronic hypertension impairs cerebral vasomotor reactivity (CVR), a marker of cerebral autoregulation. Changes in CVR may reflect impairment in the homeostasis of blood pressure in the brain, hence cerebral perfusion becomes more dependent on the systemic blood pressure. Ischemia occurs in response to drop of systemic blood pressure and lead to hypoperfusion and subsequently the development of SVD. Using Transcranial Doppler (TCD) ultrasonography, our group previously showed that decreased CVR is associated with SVD. Reduced CVR is linked to cognitive decline, depression and poor physical functions in elderly persons. Physical exercise may lead to significant improvement in CVR. These data suggest that physical exercise is likely to benefit cognition, mood and physical functions in persons with SVD due to its positive effects on CVR. Dancing as a mean of physical activity intervention Dance is a rhythmic movement usually performed with music. To many, it is a pleasurable activity that can be taken up as a hobby and social activity and therefore engagement can be self-sustaining. It is of minimal-cost and can be performed even in older persons with physical and cognitive impairment. Dancing involves movement of the body and limbs and is in itself a physical training. It also involves memory, attention, sensory stimulation, social interaction, emotional perception and expression that presumably could protect against cognitive decline and depression. Dance training may improve verbal fluency, word list delayed recall and word list recognition in older adults with metabolic syndrome, suggesting that dance may be effective in preventing cognitive decline. Aerobic dance also has been shown to enhance exercise endurance strength, balance, agility and gait performance in older adults. Our team had previously designed and implemented a balance dance to a group of patients with PD for 8 weeks. Together with other training, balance ability and walking speed increased and the effects lasted for 12 months after treatment completion. Given the likely positive effects of aerobic dance, it appears to be a good exercise candidate for enhancing cognitive, mood and physical functions in patients with cerebral SVD. Data Collection Assessment of cognitive functions The 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocols will be used. The 30-minute protocol provides a comprehensive assessment of cognitive functions with emphasis on executive functions, psychomotor speed and memory, which are the cognitive domains predominately impaired in VCI. With support from Health and Health Service Research fund (PI: Vincent CT MOK; Reference Number 06070231), the investigators adapted and validated the 30-minute protocol in a group of Chinese stroke patients and controls and demonstrated good external validity (area under ROC=0.79 [95%CI 0.69-0.89], p<0.001) in differentiating stroke patients from non-stroke controls and concurrent validity with functional measures. In addition to the 30-minute protocol, the digit span tests from the Wechsler Memory Scale will be administered because of the involvement of immediate attention and working memory in VCI. Measure of depressive symptoms The 15-item Geriatric Depression Scale (GDS), which is a self-reported questionnaire to rate depressive symptoms in elderly persons, will be used. It has been used in local study on SVD patients and demonstrated excellent classification power >90% in detecting depression in the local elderly population. Measures of physical functions The Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used to assess dynamic balance performance of individuals. The 14-item Mini-BESTest represents 4 dynamic balance domains: anticipatory postural adjustments, postural responses, sensory orientation and stability in gait. Each item is rated from 0 to 2, and the total score ranges from 0-28 with a higher score indicating better balance. The Timed-up-and-go test (TUG) will be used to examine functional mobility of subjects. This test measures the time which participants takes to rise from the chair, walk 3 meters, turn around, walk back to the chair and sit down. The 6-minute walk test will be used to determine the walking capacity. This test measures the distance (in metres) participants walk in 6 minutes. Participants will walk at their own speed, and stops and resting are allowed if necessary. Measure of daily functions The Lawton's Instrumental Activities of Daily Living (IADL) will be used to assess complex activities of daily functions that are impaired early in patients with SVD. It take about 10 minutes to administer and contains 8 items including ability to use telephone, shopping, food preparation, housekeeping, laundry, taking transportation, handling medications and finances. It is has been used as a primary outcome instrument in the Pan-European Leukoaraiosis and Disability in the Elderly Study in SVD. Measure of overall physical activities Physical activities performed outside of training session will be recorded using the long form of the International Physical Activity Questionnaire (IPAQ). The IPAQ has been very widely used in studies of physical activity across different ages and medical conditions (http://www.ipaq.ki.se/publications.htm). The IPAQ records the types, frequency and duration of physical activities across 4 activity domains including leisure time physical activity, domestic related physical activities, work-related and transportation related physical activities. The IPAQ yields scores for walking, moderate-intensity and vigorous-intensity activities with each of these activity domains. A total score is calculated by summing the duration and frequency for all types of activities across all domains. This score will be used to account for the potential confounding effects of physical activities performed outside of training session in both groups. It is estimated that it takes approximately 2 hours to complete the assessment and TCD examination. To avoid rater bias, the research assistant (RA) who performs the study assessment will be blind to treatment allocation and encouraged not to discuss with the participants about the interventions. Clinical assessments will be performed by a trained RA under the supervision of a qualified clinical psychologist (PI of this application). TCD Examination TCD examination will be performed at baseline, weeks 12, 24 and 36. A 2-MHz pulsed Doppler hand-held probe is used to insonate the middle cerebral artery (MCA) through temporal window above the zygomatic arch at a depth of 52-56mm, and the vertebral artery (VA) through occipital window at a depth of 64mm. The Pulsatility Index (PI) and Breath Holding Index (BHI) will be calculated. The PI is a measure of vascular resistance of cerebral vessels. The mean PI of the middle MCA and vertebral VA will be obtained. A previous study by the investigators showed that these measures highly differentiated stroke patients with and without WML on MRI (AUC = 0.85 [MCA] and 0.81 [VA], sensitivity and specificity between 70 and 82%]). According to the standard protocol, the simple breath holding procedure will be performed during the same TCD session to obtain the BHI, which will serve as a marker of CVR. A trained postgraduate research student under the supervision of a broad certified neurologist (Co-A Vincent MOK) will perform the TCD blind to participant's treatment allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease
Keywords
Cerebral small vessel disease, Lifestyle modification, Physical activity, Primary prevention, Aerobic dance, Cognition, Depression, Activities of daily living, Cerebral autoregulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured Aerobic Dance Training Group
Arm Type
Active Comparator
Arm Description
Active intervention will last for 24 weeks and consists of 60-minute/session, which includes 10 minutes warm-up, 40 minutes of dancing and 10 minutes of cool down. In groups of 5, participants will practice the dance led by a physiotherapist once per week for the first 2 months and twice per week for 3rd to 6th month.
Arm Title
Stretching plus education
Arm Type
Placebo Comparator
Arm Description
Participants in the control group will receive a weekly 3-hour group-based (group of 5 participants) programme containing stretching exercise, stress reduction and health education on dementia and stroke prevention for 6 months. The programme consists of low-intensity seated stretching, psychoeducation on stress management, various relaxation methods with practice as well as education on the causes, identification, treatment and prevention of stroke and dementia. Benefits of physical exercise will also be discussed but will its weight will be evenly balanced with other forms of evidence-based preventive strategies.
Intervention Type
Behavioral
Intervention Name(s)
Structured Aerobic Dance Training Group
Intervention Description
Systematic physical activity
Intervention Type
Behavioral
Intervention Name(s)
Stretching plus education
Intervention Description
Weekly group based stretching with psychoeducation and health education
Primary Outcome Measure Information:
Title
Cognition assessed by the 30-minute protocol of the National Institute of Neurological Diseases and Stroke - Canadian Stroke Network VCI protocol summary score
Time Frame
Change from baseline to week 24
Title
Depressive symptoms evaluated the Geriatric Depression Scale
Time Frame
Change from baseline to week 24
Title
Physical balance measured by the Mini-Balance Evaluation Systems Test
Time Frame
Change from baseline to week 24
Title
Functional mobility measured by the Timed-up-and-go test
Time Frame
Change from baseline to week 24
Title
Walking capacity assessed by the 6-minute walk test
Time Frame
Change from baseline to week 24
Title
Daily functioning evaluated by the Lawton's Instrumental Activities of Daily Living
Time Frame
Change from baseline to week 24
Secondary Outcome Measure Information:
Title
Cerebral vasomotor reactivity measured by Pulsatility Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler
Time Frame
Change from baseline to week 24
Title
Cerebral vasomotor reactivity measured by Breath Holding Index obtained from middle cerebral artery and vertebral artery measured on Transcranial Doppler
Time Frame
Change from baseline to week 24
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events or serious adverse events
Description
Adverse events and serious adverse events will be reported to the Chinese University of Hong Kong - New Territories East Cluster Ethics Committee according to standard reporting guidelines
Time Frame
Throughout the entire study period up to 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥65 Community dwelling Presence of significant SVD, defined by the presence of multiple (≥2) lacunar infarcts and/or a rating of ≥2 (i.e. beginning confluence of lesions to diffuse involvement of lesions in periventricular and/or deep white matter) of WML using the Age-related White Matter Changes (ARWMC) Scale on MRI Presence of good temporal window on at least one side for TCD evaluation Written informed consent given Exclusion Criteria: History of stroke Dementia, determined by a score on Cantonese MMSE less than education adjusted cutoff score for dementia or history of dementia diagnosis Comorbidity with medical conditions affecting the central nervous system or cerebral white matter Inadequately controlled psychiatric disorders affecting cognition and mood Physical or sensory impediments hindering participation in cognitive assessment or exercise training.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian Wong, PhD
Phone
852-25587122
Email
adrianwong@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Wing Lam Kwan, MSoSc
Phone
852-26352160
Email
paulinekwan@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Wong, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Chau, BSc
Facility Name
Neurology Clinical Research Centre, CUHK
City
Shatin
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Wong, PhD
Phone
852-25587122
Email
adrianwong@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Pauline Wing Lam Kwan, MSoSc
Phone
852-26352160
Email
paulinekwan@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Margaret Kit Yi Mak, PhD
First Name & Middle Initial & Last Name & Degree
Linda CW Lam, MD
First Name & Middle Initial & Last Name & Degree
Vincent Chung Tong Mok, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Aerobic Dance Training in Small Vessel Disease

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